|Publication number||US6173200 B1|
|Application number||US 09/053,465|
|Publication date||Jan 9, 2001|
|Filing date||Apr 1, 1998|
|Priority date||Apr 4, 1997|
|Also published as||CA2201800A1, CA2201800C|
|Publication number||053465, 09053465, US 6173200 B1, US 6173200B1, US-B1-6173200, US6173200 B1, US6173200B1|
|Inventors||T. Derek V. Cooke, Brian Kelly, Gerry Saunders|
|Original Assignee||T. Derek V. Cooke, Brian Kelly, Gerry Saunders|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (8), Referenced by (57), Classifications (12), Legal Events (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to the field of orthopaedics. In particular, the present invention provide a method and apparatus for axial referencing for surgery involving joints with condyles, such as the knuckle (metacarpo and metatarsophalangeal) joints of hands and feet, elbow and knee.
A condyle is the rounded projection at the end of a bone, such as the femur. Condyles may be found in pairs and define rotational bearing surfaces for the joint providing movement mostly in one place (sagittal). Each condyle is shaped generally like a partial disk, with a rounded perimeter, and an outwardly projecting bulge known as the ‘epicondyle’.
When a surgeon replaces a joint, such as at the knee, the surgeon will generally reference location of the dissected prosthetic and the prosthetic joint around and to -cover the dissected condylar elements. This is done so that the joint will flex sufficiently to provide a functional angle of motion that is some 90° and reproducible. It is known that ideally, the prosthesis placement ought to be referenced to the transverse axis of the joint, but defining this axis in an accurate reproducible way is generally not possible. Moreover, the transverse axis of the joint is not stationary, but will vary with the state of flexion of the joint. At the knee, however, the transverse axis for motion is approximate with a line joining the epicondyles. An objective therefore is to locate the prosthetic joint appropriately about this transepicondylar line (axis). The problem with this approach has been that the epicondyles are somewhat rounded, making it difficult for the surgeon to accurately locate the most prominent outer aspects of each epicondyle with certainty by viewing the dissected joint. Moreover, the outer aspects of the epicondyles are not reliably visible on frontal or lateral radiographs, because the knee cannot be positioned to radiograph the epicondyles in profile due to overlap of condylar bone. Furthermore, the epicondyles are not readily palpable by hand through the skin. The exception for this is the elbow.
The object of the present invention, therefore, is to provide a method and apparatus for reliably and reproducibly locating the most prominent outer aspects of the epicondyles of a bone such as the femur. This permits a surgeon or technician to locate the transepicondylar line (TEL) of the joint, and use this as the reference the transverse axis of motion about which the location of the condylar portion of the joint prosthesis is then located. The resultant implant is thereby more anatomically located, and capable of flexion without excessive strain or stress on any surrounding tissue usually for more than 90°. A collateral benefit of the method of the present invention is that it provides a wealth of preoperative data to an orthopaedic surgeon, who is then given the opportunity to order precisely sized joint prosthetics well in advance of surgery. This permits an institution to maintain a smaller inventory of joint prosthetics, at a fairly low cost.
In a broad aspect, then, the present invention relates to a method for determining the transepicondylar line of a bone exhibiting condyles and therefore locating the transverse axis of rotation comprising the steps of: (a) conducting a computer tomographic (CT) scan from the end of the condyles inwardly, transverse to the anatomical axis of the bone with the bone facing forwardly; (b) selecting the CT slice image exhibiting maximum epicondylar width and establishing a line between the epicondyles at the widest extent; (c) establishing a line joining the posterior tangents of the condyles on said CT image; (d) establishing measured lines from the posterior condylar tangent line at right angles to the said line between said epicondyles.
In another broad aspect, the present invention relates to a device for locating the epicondyles on a bone that has been prepared by the insertion of a intramedullary rod along the anatomical axis thereof comprising: (a) a body bracket for fixation to said intramedullary rod, against the distal end of said bone; (b) a foot plate depending from said body bracket, adjustable to bear against the posterior surface of a condyle, to fix said body bracket in a -known orientation; (c) a measuring arm extending in the direction of said bone from said bracket, adjustable according to imaging data to locate and permit the marking of a said epicondyle.
In drawings which illustrate the present invention by way of example:
FIG. 1A is a frontal view of a knee joint;
FIG. 1B is an axial view of the distal end of a femur, aligned with a tibia;
FIG. 2 is a schematic of a knee in flexion, prepared for prosthesis implantation;
FIG. 3 is a schematic of a CT image through the epicondyles of a femur;
FIG. 4 is a side view of a first embodiment of the apparatus of the present invention attached to a femur;
FIG. 5 is a rear view thereof;
FIG. 6 is an underside view thereof; and
FIG. 7 is a perspective view thereof.
This invention will be illustrated by reference to the knee joint, but it will be understood that the invention function equally well in regards to other joints where condyles form the major bearing surface for mainly flexion about a central (horizontal) axis.
As depicted in FIG. 1A, normal alignment of stance shows the knee. joint line close to horizontal (T) with femoral condylar tangent (FCT) and matching tibial plateaus (TP) inclined three degrees inwardly to a load axis that passes from the foot to the hip on which the knee is centred. In this position the femoral mechanical axis (FMA), being a line joining femoral head to knee centre, is vertical and coincident with the tibial shaft, also its mechanical axis (TMA). In contrast, the femoral shaft anatomic axis (FAA) is angled some 6° to FMA. Referenced from the respective AA the femoral condylar tangent would be 9° valgus more than 90°, whereas tibial plateau would incline 3° varus less than 90° to shaft.
FIG. 1B shows an axial orientation of the femur in which the transverse axis is horizontally disposed as line TEL. Note the condylar asymmetry posteriorly reflected by greater posterior prominence medially than laterally. Moreover, neither distal femur or proximal tibia are regularly shaped or parallel to the transverse axis.
FIG. 2 is a schematic of the knee in flexion, prepared for knee implantation in which condylar curve of the implant is located about TEL determined as the transverse axis for rotation.
The TEL is located in the following manner. First, full length frontal standing radiographs of the entire leg, and standing lateral (central on the knee) positioned with flexion plane ahead radiographs are taken. These are used to locate the mechanical and anatomical shaft axis of the femur and tibia.
A CT (computer tomographic) scan of the distal femur is then undertaken, with the subject supine, knee flexion plane ahead, and lower legs parallel with slice separations of, typically 1 mm, through the condylar portion of the femur, including the patella and intracondylar groove.
As can be seen in FIG. 3, the outermost aspects of the epicondyles are determinable on a CT slice. The distance of each slice from the distal most aspect of the femur is known. The most outward points of the medial and lateral epicondyle are defined, marked and connected by a line drawn through them. This is the transepicondylar line (TEL) and transverse axis. On the same CT slice, the tangents to the posterior condyles (most posterior projection) are identified and connected by a line. The angle between TEL and the posterior condylar tangent is measured. The centres of each condyle (at the tangent points), centre of the patella groove (G) and centres of each medial and lateral patella flange of the femur as well as the epicondylar tips are identified as points which are connected by lines drawn perpendicular from the TEL to each of them. These interconnections provide the dimensional measures of femoral condylar geometry referenced to the TEL. They are:
TEL-LFC/MFC. Perpendicular distances from TEL to respective condylar tangents—represent condylar depths (and radii);
PCL (Posterior cruciate ligament) point location at TEL—represents the knee mediolateral centre;
PCL distance to medial (MO or lateral (L) epicondyle [condylar width];
TEL-G—Sulcus location and height at TEL.
The condylar depths and radii thus measured, and overall femoral width at the TEL provides the surgeon with precise sizing and locating information.
The long leg radiograph gives information to define femoral geometry in frontal plane. From it the femoral mechanical axis (MA) is drawn and referenced for its variance to the anatomic axis. (Usually about 6°-7°). The lateral radiograph defines any unusual curvature of the bone to the hip.
In the operating room four points are established of distal femoral geometry that will be used to define each medial and lateral epicondyle and subsequently the TEL. These are:
Posterior cruciate ligament attachment at its anterolateral point;
Medial femoral tangent posteriorly;
Lateral femoral tangent posteriorly.
Referring now to FIGS. 4, 5, 6 and 7, the instrument and method of the present invention are illustrated. Preparatory to utilizing the present invention, the distal femur is penetrated above the PCL point at A, and an intramedullary rod is inserted into the shaft of the femur defining the anatomic axis of the femur. The rod is immobilized with a sliding bushing.
The TEL locating device of the present invention is shown in FIGS. 4, 5, 6 and 7. This device is utilized to locate and mark the outermost aspects of the femoral condyles one at a time. It includes a central bracket 1 with a central bored through slot 2 that is dimensioned to permit the bracket to be slid onto and fixed on the intramedullary rod (IR) that has been inserted in the femur, as aforesaid. The slot is wide enough to accommodate a wide range of intracondylar widths, and is marked (not illustrated) to permit accurate placement.
At one end of the bracket a rod 3 is mounted in a sleeve 4 fixed to the end of the bracket. The sleeve is provided with a set screw 5, to fix the rod 3 at any desired height. The rod is marked along its length so as to be easily set for height.
One end of the rod is provided with a foot 6 plat that extends forwardly, to contact the posterior surface of a condyle. A forwardly projecting measuring and positioning arm is mounted on the rod, between the bracket and the foot plate. The measuring arm may be fixed on the rod by means of a thumb screw 8, provided on the end of the measuring element.
In order to utilize the device of FIGS. 4 to 7, measurements taken from the CT scan slice diagram exemplified by FIG. 3 are utilized. The position A of the intramedullary rod through the anatomical axis of the femur, is known. A line B is drawn through that position, parallel to the posterior femoral tangent, and measurements taken from that line to the posterior femoral tangent. This provides the height setting for the rod at the end of the tangent. Epicondylar tangent lines L-L′ and M-M′ provide the settings, on each side, for the measuring arms. These tangent lines are then extrapolated to intersect the line through the anatomical axis of the femur, providing the setting for the point of fixation of the bracket on the intramedullary rod.
With the foregoing measurements known, the rod is first fixed on the bracket at the desired height. The bracket is then slid onto the intramedullary rod, and adjusted lateromedially to the desired location, as measured in the manner described above, and fixed in position (fixation means not illustrated), with the foot plate in contact with the posterior of a selected condyle (illustrated is the lateral one). The measuring arm is then brought to the desired, premeasured height, and pivoted over into contact with the epicondyle. The thumbscrew on the measuring arm is then tightened. The arm is provided with marked gradations of measurement, corresponding to the position of CT image slices. As illustrated, there may be a series of apertures 9, but other methods of marking gradations may be used. The correct point according to the level of the CT image is chosen, and the epicondyle marked for instance by a pin 10. The process is repeated for the other side of the femur, with the bracket inverted and the rod reinserted. At this time it may be necessary to consult a different CT image slice, if the two epicondyles were not located on the same image.
Utilizing the present invention precisely defines two critical axes from which all further measurements and bone preparative steps are made. These may be checked against CT and plain radiograph data from time to time during surgery. These include:
Anterior patella groove height. G-TEL
Posterior condylar depth TEL-MFC, TEL-LFC
Mean condylar depth mid-point between MFC/LFC
Condylar width at TEL.
It will be understood that the mechanical configuration of the device of the present invention may be easily altered without departing from the present invention. For instance, the foot plates may be constructed to slide medially/laterally, and in this instance, the L-shaped square may be replaced by a calibrated rod. Alternatively, a calibrated protractor centred at the PCL point may be used to define an angle from the transepicondylar axis to the PC tangent. Once set, the protractor arm is moved to a preset location at centre defining the ends of the transepicondylar axis.
The TEL locating information derived from the first part of the method of the present invention may also be used to define the TEL by means of known three dimensional computerized magnetic tracking techniques. With the joint immobilized, the TEL may be precisely located by its position relative to the distal end of the femur, and the posterior tangent of the condyles, both of which may be reliably located in a joint dissection. The angular orientation and distance of the epicondyles relative to these two lines derived by the method of the present invention may be utilized to quickly and efficiently locate the TEL by thee dimensional magnetic tracking.
It is to be understood that the examples described above are not meant to limit the scope of the present invention. It is expected that numerous variants will be obvious to the person skilled in the field of orthopaedic instrument design without any departure from the spirit of the invention. The appended claims, properly construed, form the only limitation upon the scope of the invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4474177 *||Mar 9, 1983||Oct 2, 1984||Wright Manufacturing Company||Method and apparatus for shaping a distal femoral surface|
|US4703751 *||Mar 27, 1986||Nov 3, 1987||Pohl Kenneth P||Method and apparatus for resecting a distal femoral surface|
|US5281224 *||Jan 5, 1993||Jan 25, 1994||Orthofix S.R.L.||Centering means for holes of intramedullary nails|
|US5514137 *||Dec 6, 1993||May 7, 1996||Coutts; Richard D.||Fixation of orthopedic devices|
|US5601563 *||Aug 25, 1995||Feb 11, 1997||Zimmer, Inc.||Orthopaedic milling template with attachable cutting guide|
|US5720752 *||Feb 21, 1996||Feb 24, 1998||Smith & Nephew, Inc.||Distal femoral cutting guide apparatus with anterior or posterior referencing for use in knee joint replacement surgery|
|US6090114 *||Jun 29, 1999||Jul 18, 2000||Stryker Howmedica Osteonics Corp.||Tibial plateau resection guide|
|US6106529 *||Dec 18, 1998||Aug 22, 2000||Johnson & Johnson Professional, Inc.||Epicondylar axis referencing drill guide|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6258097 *||Jun 2, 2000||Jul 10, 2001||Bristol-Myers Squibb Co||Head center instrument and method of using the same|
|US6468280 *||Jul 24, 2000||Oct 22, 2002||Sulzer Orthopedics Inc.||Unicompartmental replacement instrument and method|
|US6645214||Nov 12, 2001||Nov 11, 2003||Depuy Orthopaedics, Inc.||Apparatus and method for bone positioning|
|US6709459 *||Aug 31, 2000||Mar 23, 2004||Mayo Foundation For Medical Education And Research||Radial implant system|
|US6915150||Mar 8, 2002||Jul 5, 2005||Aesculap Ag & Co. Kg||Process and device for the preoperative determination of the positioning data of endoprosthetic parts|
|US7033360||Mar 19, 2004||Apr 25, 2006||Aesculap Ag & Co. Kg||Process and device for the preoperative determination of the positioning data endoprosthetic parts|
|US7101377||Jul 9, 2001||Sep 5, 2006||Ate B. Wymenga||Device for optimizing a knee endoprosthesis|
|US7618421||Nov 17, 2009||Howmedica Osteonics Corp.||Tools for femoral resection in knee surgery|
|US7828752||Oct 5, 2006||Nov 9, 2010||Arthroplasty Innovations, Llc||Device and method for locating the anteroposterior femoral axis to determine proper femoral component rotation in knee replacement|
|US7931655||Sep 10, 2009||Apr 26, 2011||Howmedica Osteonics Corp.||Methods and tools for femoral resection in knee surgery|
|US8038683 *||Oct 18, 2011||Orthosoft Inc.||CAS system for condyle measurement|
|US8460302||Jun 11, 2013||Otismed Corporation||Arthroplasty devices and related methods|
|US8460303||Oct 25, 2007||Jun 11, 2013||Otismed Corporation||Arthroplasty systems and devices, and related methods|
|US8480679||Apr 29, 2008||Jul 9, 2013||Otismed Corporation||Generation of a computerized bone model representative of a pre-degenerated state and useable in the design and manufacture of arthroplasty devices|
|US8483469||Oct 2, 2012||Jul 9, 2013||Otismed Corporation||System and method for image segmentation in generating computer models of a joint to undergo arthroplasty|
|US8532361||Jan 25, 2012||Sep 10, 2013||Otismed Corporation||System and method for image segmentation in generating computer models of a joint to undergo arthroplasty|
|US8617171||Apr 13, 2011||Dec 31, 2013||Otismed Corporation||Preoperatively planning an arthroplasty procedure and generating a corresponding patient specific arthroplasty resection guide|
|US8617175||Dec 14, 2009||Dec 31, 2013||Otismed Corporation||Unicompartmental customized arthroplasty cutting jigs and methods of making the same|
|US8715291||Aug 24, 2009||May 6, 2014||Otismed Corporation||Arthroplasty system and related methods|
|US8734455||Feb 23, 2009||May 27, 2014||Otismed Corporation||Hip resurfacing surgical guide tool|
|US8737700||Apr 14, 2010||May 27, 2014||Otismed Corporation||Preoperatively planning an arthroplasty procedure and generating a corresponding patient specific arthroplasty resection guide|
|US8777875||Jul 17, 2009||Jul 15, 2014||Otismed Corporation||System and method for manufacturing arthroplasty jigs having improved mating accuracy|
|US8801715||Mar 26, 2010||Aug 12, 2014||Lexi Corporation, Ltd.||Apparatus for preoperative planning of artificial knee joint replacement operation and jig for supporting operation|
|US8801719||Dec 28, 2012||Aug 12, 2014||Otismed Corporation||Total joint arthroplasty system|
|US8801720||Dec 18, 2006||Aug 12, 2014||Otismed Corporation||Total joint arthroplasty system|
|US8965483 *||Sep 16, 2011||Feb 24, 2015||Pierre Couture||CAS system for condyle measurement|
|US8968320||Jun 5, 2012||Mar 3, 2015||Otismed Corporation||System and method for manufacturing arthroplasty jigs|
|US9017336||Jan 19, 2007||Apr 28, 2015||Otismed Corporation||Arthroplasty devices and related methods|
|US9208263||Dec 31, 2012||Dec 8, 2015||Howmedica Osteonics Corporation||System and method for image segmentation in generating computer models of a joint to undergo arthroplasty|
|US9402637||Jan 24, 2013||Aug 2, 2016||Howmedica Osteonics Corporation||Customized arthroplasty cutting guides and surgical methods using the same|
|US9408618||Feb 23, 2009||Aug 9, 2016||Howmedica Osteonics Corporation||Total hip replacement surgical guide tool|
|US20020095083 *||Mar 8, 2002||Jul 18, 2002||Philippe Cinquin||Process and device for the preoperative determination of the positioning data of endoprosthetic parts|
|US20030069585 *||Oct 10, 2001||Apr 10, 2003||Axelson Stuart L.||Methods and tools for femoral resection in knee surgery|
|US20040039398 *||Jul 9, 2001||Feb 26, 2004||Maurizio Cortellessa||Device for optimizing a knee endoprosthesis|
|US20040181144 *||Mar 19, 2004||Sep 16, 2004||Aesculap Ag & Co. Kg||Process and device for the preoperative determination of the positioning data of endoprosthetic parts|
|US20060212124 *||Apr 30, 2004||Sep 21, 2006||Thomas Siebel||Knee joint prosthesis|
|US20070010884 *||Jun 30, 2006||Jan 11, 2007||Finsbury (Development) Limited||Prostheses|
|US20070232959 *||Jan 25, 2007||Oct 4, 2007||Pierre Couture||Cas system for condyle measurement|
|US20080139965 *||Oct 5, 2006||Jun 12, 2008||Meneghini R Michael||Device and method for locating the anteroposterior femoral axis to determine proper femoral component rotation in knee replacement|
|US20080147072 *||Dec 18, 2006||Jun 19, 2008||Ilwhan Park||Arthroplasty devices and related methods|
|US20080306485 *||Aug 20, 2008||Dec 11, 2008||Zimmer Technology, Inc.||Instruments for knee surgery and method uf use|
|US20090110498 *||Oct 25, 2007||Apr 30, 2009||Ilwhan Park||Arthroplasty systems and devices, and related methods|
|US20090131941 *||Dec 18, 2006||May 21, 2009||Ilwhan Park||Total joint arthroplasty system|
|US20090138020 *||Nov 27, 2007||May 28, 2009||Otismed Corporation||Generating mri images usable for the creation of 3d bone models employed to make customized arthroplasty jigs|
|US20090222015 *||Feb 23, 2009||Sep 3, 2009||Otismed Corporation||Hip resurfacing surgical guide tool|
|US20100004658 *||Sep 10, 2009||Jan 7, 2010||Howmedica Osteonics Corp.||Methods and tools for femoral resection in knee surgery|
|US20100023015 *||Jul 17, 2009||Jan 28, 2010||Otismed Corporation||System and method for manufacturing arthroplasty jigs having improved mating accuracy|
|US20100042105 *||Aug 24, 2009||Feb 18, 2010||Otismed Corporation||Arthroplasty system and related methods|
|US20100152741 *||Dec 14, 2009||Jun 17, 2010||Otismed Corporation||Unicompartmental customized arthroplasty cutting jigs and methods of making the same|
|US20110009868 *||Jan 13, 2011||Takashi Sato||Apparatus for preoperative planning of artificial knee joint replacement operation and jig for supporting operation|
|US20110214279 *||Sep 8, 2011||Otismed Corporation||Preoperatively planning an arthroplasty procedure and generating a corresponding patient specific arthroplasty resection guide|
|US20120010500 *||Jan 12, 2012||Pierre Couture||Cas system for condyle measurement|
|US20120172882 *||Jul 5, 2012||Takashi Sato||Apparatus for preoperative planning of artificial knee joint replacement operation and jig for supporting operation|
|USD691719||Jun 22, 2011||Oct 15, 2013||Otismed Corporation||Arthroplasty jig blank|
|CN102697558B *||Sep 3, 2008||Jul 29, 2015||株式会社力克赛||人工膝关节置换手术用工具|
|WO2004096102A1 *||Apr 30, 2004||Nov 11, 2004||Thomas Siebel||Knee joint prosthesis|
|WO2007085085A1 *||Jan 25, 2007||Aug 2, 2007||Orthosoft Inc.||Cas system for condyle measurement|
|U.S. Classification||600/425, 606/87|
|International Classification||A61F2/38, A61F2/46, A61B6/00, A61F2/30|
|Cooperative Classification||A61F2/4657, A61B6/505, A61F2/3859, A61F2002/30948|
|European Classification||A61B6/50J, A61F2/46M|
|May 29, 2001||CC||Certificate of correction|
|Jun 18, 2004||FPAY||Fee payment|
Year of fee payment: 4
|Jun 25, 2008||FPAY||Fee payment|
Year of fee payment: 8
|Aug 20, 2012||REMI||Maintenance fee reminder mailed|
|Jan 2, 2013||FPAY||Fee payment|
Year of fee payment: 12
|Jan 2, 2013||SULP||Surcharge for late payment|
Year of fee payment: 11